Brief Title
Lung Cancer Mutation Consortium Protocol
Official Title
Lung Cancer Mutation Consortium Protocol
Brief Summary
The primary objective of this protocol is to determine the frequency of oncogenic mutations in 1000 patients with advanced adenocarcinoma of the lung. The linked clinical and mutational analyses will be used to determine the frequency of each mutation, its association with clinical features and outcome, and its association with other mutations. As future therapeutic protocols specific for these mutations are developed, patients may be notified of their eligibility for these studies. Future translational studies may be used to: a) unravel the complex biology of lung cancer; b) identify prognostic markers; c) define predictive markers of response/resistance to new therapies; d) identify new targets. A secondary goal is to establish a consortium of sites that have the capability of conducting multiple mutation testing in a Clinical Laboratory Improvement Amendments (CLIA) certified lab.
Study Type
Observational
Primary Outcome
Frequency of oncogenic mutations in patients with advanced adenocarcinoma of the lung.
Secondary Outcome
Associations between each mutation and clinical outcomes.
Condition
Adenocarcinoma of Lung, Stage IV
Study Arms / Comparison Groups
Advanced Adenocarcinoma
Description: Stage IV adenocarcinoma who have undergone biopsy with remnant tissue.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
1100
Start Date
September 16, 2009
Completion Date
September 30, 2024
Primary Completion Date
September 1, 2016
Eligibility Criteria
Inclusion Criteria: 1. Subjects (=> 18 years of age) who are undergoing further evaluation for the diagnosis or treatment of advanced adenocarcinoma of the lung. 2. Diagnosed May 2012 or later 3. Oral and written informed consent. Exclusion Criteria: 1. Lung cancer histologies other than adenocarcinoma 2. Lack of adequate tissue.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Paul Bunn, M.D., ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01014286
Organization ID
09-0756.cc
Responsible Party
Sponsor
Study Sponsor
University of Colorado, Denver
Study Sponsor
Paul Bunn, M.D., Study Director, University of Colorado, Denver
Verification Date
January 2023